Coping Skills and Heart Failure: Outcomes and Mechanisms (COPE-HF)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00873418
First received: March 30, 2009
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

This study will evaluate whether heart failure patients receiving a 16 week telephone delivered, intervention using cognitive behavior therapy to facilitate self-management of heart failure will have better clinical outcomes than heart failure patients receiving a 16 week heart failure education intervention via telephone.


Condition Intervention
Heart Failure
Behavioral: Coping skills training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Coping Skills Training in Heart Failure: Outcomes and Mechanisms

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Time to death or hospitalization [ Time Frame: yearly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life Outcome measures [ Time Frame: yearly ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: March 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Coping Skills Training
16 week telephone intervention using coping skills training to teach heart failure patients self-management skills and how to cope more effectively with psychological distress associated with heart failure.
Behavioral: Coping skills training
16 weekly telephone session using to teach heart failure patients self-management skills and how to cope more effectively with psychological distress associated with heart failure.
Other Name: COPE-HF
Active Comparator: Educational Control
16 weekly telephone calls for extended (standardized) care on heart failure education.
Behavioral: Coping skills training
16 weekly telephone session using to teach heart failure patients self-management skills and how to cope more effectively with psychological distress associated with heart failure.
Other Name: COPE-HF

Detailed Description:

Over 5 million Americans suffer from heart failure (HF), with an associated annual health care cost in excess of $33 billion. With 500,000 new cases developing each year, HF is the only major cardiovascular disease that is increasing in prevalence. Despite intensive medical therapy, symptom instability and clinical deterioration are common and lead to frequent physician visits, hospitalization, and ultimately death. HF symptoms, including dyspnea and fatigue, are a major source of distress for patients with HF, and often impose severe limitations on their daily activities. Depression also is common in HF patients, and its presence is associated with increased risk of hospitalization and mortality, independent of disease severity. There is growing evidence that behavioral management is a critical component of living with HF that can reduce hospitalizations and help optimize health status. Although previous studies have demonstrated that case-management programs are effective, benefits appear to be short-lived once ongoing care is reduced. Prior research from our laboratory and others has shown that coping skills training (CST), designed both to teach patients self-management skills and to cope more effectively with psychological distress associated with their medical condition, is effective for such chronic diseases as diabetes, ischemic heart disease, and lung disease. However, CST has not yet been evaluated as an intervention to facilitate self-management of HF. We propose a randomized clinical trial comparing a 16-week CST intervention with Extended (Standardized) Care in a study sample of 200 HF outpatients, who are receiving medical treatment for HF according to current clinical practice guidelines. The CST intervention, delivered over the telephone, is designed reduce stress and depression and to improve aspects of health behavior that are related to HF outcomes, including symptom monitoring, medication adherence, dietary compliance, and physical activity. Before and following treatment, patients will be carefully assessed on important intermediate medical endpoints including HF disease biomarkers (B-type natriuretic peptide, ejection fraction, vascular endothelial function, autonomic regulation, and inflammatory activity), as well as on quality of life (QoL) indicated by both physical and psychosocial functioning. Effects of CST on clinical outcomes will be evaluated according to all-cause hospitalizations or mortality over a median follow-up period of 3 years. The data generated by the proposed study will provide important insights regarding the value of CST over and above usual medical care. If successful, we believe that the study findings should translate into initial recommendations for the incorporation of CST into self-management behavioral interventions as cost-effective approaches to enhance disease management, QoL and longevity in HF patients.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women aged 21 years or older
  • New York Heart Association (NYHA) Class I-IV HF of at least 3-months duration
  • Left ventricular Ejection Fraction (EF) < 40% by left ventricular angiography, nuclear wall motion study, or echocardiography, within 6 months of study enrollment
  • Undergoing treatment with a stable medication regimen.

Exclusion Criteria:

  • Myocardial Infarction (MI), Percutaneous Transluminal Coronary Angioplasty(PTCA), Coronary Artery Bypass Graft (CABG) within 3 months of enrollment
  • HF due to correctable cause or condition such as uncorrected primary valvular disease
  • Alcohol or drug abuse within 12 months
  • Illness such as malignancies that are associated with a life-expectancy of < 12 months
  • Current pregnancy
  • Inability to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873418

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Andrew Sherwood, PhD Duke University
  More Information

No publications provided by Duke University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00873418     History of Changes
Other Study ID Numbers: Pro00009707, 1 RO1 HL091920-01A1
Study First Received: March 30, 2009
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Heart Failure
Intervention
Cognitive Behavior Therapy
Quality of Life

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014